Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement?

NCT02921880 | Completed

• 1 other identifier: 16/OO/0687
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the remaining 15 patients will receive standard of care. All patients will return to clinic at 3 months and 6 months post implant and undertake the functional, independence, frailty and emotional testing again.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients willing to undertake cardiac rehabilitation following TAVR.

  6 months

Secondary Outcomes (3)

• Functional capacity by 4 metre gait speed.

  6 months

• Frailty assessment via the FRIED criteria.

  6 months

• Hospital Anxiety and Depression score

  6 months

Study Arms (2)

Cardiac Rehabilitation

EXPERIMENTAL

Patients will return to the out-patient clinic at 4 weeks post - TAVR and research consent will be re-affirmed. Patients will be randomised to receive a programme of cardiac rehabilitation or routine care at this point. Patients randomised to receive cardiac rehabilitation will meet the cardiac rehab team and undergo baseline assessment for the programme. This involves recording height, weight, blood pressure, oxygen saturation and heart rate and rhythm. An individualised programme will be established to meet the needs of each patient. The patients will undergo a 6 week programme of cardiac rehab. Patients who are not allocated to the intervention group will not receive a cardiac programme and will have access to the TAVR nurse specialist team as would be usual care.

Other: Cardiac Rehabilitation

Standard of care

NO INTERVENTION

15 patients will be randomised to receive a programme of cardiac rehabilitation, and 15 patients will receive standard of care which does not include a routine rehabilitation programme.

Interventions

Cardiac Rehabilitation OTHER

Cardiac Rehabilitation

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Severe symptomatic aortic stenosis accepted for Trans Catheter Aortic Valve Replacement
• Age ≥75 years;
• Participant able and willing to give written informed consent;
• Participant able (in the Investigator's opinion) and willing to comply with all study requirements.

You may not qualify if:

• Subjects may not enter the study if ANY of the following apply:
• Intervention deemed inappropriate due to co-morbidity or frailty;
• Life expectancy less than one year due to co-morbidity;
• Previous AVR or TAVI;
• Predominant aortic regurgitation (AR).

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

Uxbridge, Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (4)

• Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.

  PMID: 18848134 BACKGROUND

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Reynolds MR, Magnuson EA, Lei Y, Leon MB, Smith CR, Svensson LG, Webb JG, Babaliaros VC, Bowers BS, Fearon WF, Herrmann HC, Kapadia S, Kodali SK, Makkar RR, Pichard AD, Cohen DJ; Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.

  PMID: 21969017 BACKGROUND

• Rogers P, Al-Aidrous S, Banya W, Haley SR, Mittal T, Kabir T, Panoulas V, Raja S, Bhudia S, Probert H, Prendergast C, Spence MS, Davies S, Moat N, Taylor RS, Dalby M. Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study: RECOVER-TAVI Pilot, ORCA 4, For the Optimal Restoration of Cardiac Activity Group. Pilot Feasibility Stud. 2018 Dec 13;4:185. doi: 10.1186/s40814-018-0363-8. eCollection 2018.

  PMID: 30564436 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 3, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 13, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

GB (1)